FDA.reportPublic FDA data

Excedrin

Product NDC
0067-2042
11-digit product format
000672042
Labeler code
0067
Product ID
0067-2042_27f2895c-750b-4c97-9d33-914f4df59bd2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin (NSAID), Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
NDA020802
Marketing category
NDA
Marketing start
2024-01-01
Substance
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength
250; 250; 65 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Excedrin
Brand name suffix
Migraine Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN250 mg/1
ASPIRIN250 mg/1
CAFFEINE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, R16CO5Y76E, 3G6A5W338E
Rxcui209468, 308297

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-2042-01ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-01ExcedrinMigraine Relief24 in 1 BOTTLETABLET, FILM COATED244
0067-2042-02ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-02ExcedrinMigraine Relief30 in 1 BOTTLETABLET, FILM COATED304
0067-2042-03ExcedrinMigraine Relief50 in 1 BOTTLETABLET, FILM COATED504
0067-2042-03ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-04ExcedrinMigraine Relief100 in 1 BOTTLETABLET, FILM COATED1004
0067-2042-04ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-05ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-05ExcedrinMigraine Relief125 in 1 BOTTLETABLET, FILM COATED1254
0067-2042-06ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-06ExcedrinMigraine Relief200 in 1 BOTTLETABLET, FILM COATED2004
0067-2042-07ExcedrinMigraine Relief250 in 1 BOTTLETABLET, FILM COATED2504
0067-2042-07ExcedrinMigraine Relief1 in 1 CARTONTABLET, FILM COATED14
0067-2042-08ExcedrinMigraine Relief300 in 1 BOTTLETABLET, FILM COATED3004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-2042-04EA - Each0067-20429de6e1fd-7116-4c59-8467-9676b0ad021912024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-2042EXCEDRIN MIGRAINE RELIEF (ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE) TABLET, FILM COATED [HALEON US HOLDINGS LLC]4Current NDC, 15 package rows20250315_dd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletPSNdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
209468EXCEDRIN 250 MG / 250 MG / 65 MG Oral TabletPSNdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
209468acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet [Excedrin]SBDdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
308297acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral TabletSCDdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
308297APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral TabletSYdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
209468APAP 250 MG / ASA 250 MG / Caffeine 65 MG Oral Tablet [Excedrin]SYdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
209468Excedrin Extra Strength (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
209468Excedrin Menstrual Complete (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84
209468Excedrin Migraine (APAP 250 MG / ASA 250 MG / caffeine 65 MG) Oral TabletSYdd85f3a7-f4d2-4ea0-a7b6-18ebc0e993d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-2042-01000672042011 BOTTLE in 1 CARTON (0067-2042-01) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-02000672042021 BOTTLE in 1 CARTON (0067-2042-02) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-03000672042031 BOTTLE in 1 CARTON (0067-2042-03) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-04000672042041 BOTTLE in 1 CARTON (0067-2042-04) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-05000672042051 BOTTLE in 1 CARTON (0067-2042-05) / 125 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-06000672042061 BOTTLE in 1 CARTON (0067-2042-06) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-07000672042071 BOTTLE in 1 CARTON (0067-2042-07) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2024-01-01NoNoHistorical
0067-2042-0800067204208300 TABLET, FILM COATED in 1 BOTTLE (0067-2042-08) 2024-01-01NoNoHistorical